Oramed Announces Oravax's Oral COVID-19 Vaccine Has Received South African Approval to Initiate Phase 1 Trial
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) announced that its subsidiary, Oravax Medical Inc., received clearance from the South African Health Products Regulatory Authority to initiate a Phase 1 clinical trial for its oral COVID-19 vaccine. This vaccine utilizes virus-like particle technology targeting three SARS-CoV-2 proteins, potentially enhancing efficacy against variants. The trial, which aims to simplify vaccine distribution by allowing self-administration, is set to begin shortly, with plans for a Phase 2/3 trial for emergency approval following successful results.
- Received regulatory clearance for Phase 1 trial of oral COVID-19 vaccine.
- Utilizes scalable virus-like particle technology targeting less mutable virus proteins.
- Potential for self-administration, improving distribution efficiency.
- None.
NEW YORK, Oct. 29, 2021 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today announced that its majority-owned subsidiary, Oravax Medical Inc. (www.ora-vax.com), has received clearance from the South African Health Products Regulatory Authority to commence patient enrollment in a first in human, Phase 1 clinical trial, for its oral COVID-19 vaccine and preparations to begin the trials are now underway.
Oravax's virus-like particle (VLP) vaccine technology targets three SARS CoV-2 virus surface proteins, including proteins less susceptible to mutation, thus making the vaccine potentially more effective against current and future variants of the COVID-19 virus. Oravax's VLP vaccine technology is highly scalable and easily transferable.
"We believe that Oravax's oral COVID-19 vaccine candidate could offer an exciting potential solution to the COVID pandemic, whether as a booster or for the unvaccinated. An oral COVID-19 vaccine would eliminate several barriers to rapid, widescale distribution, potentially enabling people to administer the vaccine themselves at home," stated Oramed CEO Nadav Kidron. "Following this Phase 1 trial, our intention is to move forward with a Phase 2/3 trial for emergency use approval in relevant countries," Kidron concluded.
For more information on Oravax's VLP technology view the video: https://www.youtube.com/watch?v=98ZZctr4vZI
About Oravax
Oravax Medical Inc. was established in 2021 by Oramed Pharmaceuticals Inc., the largest shareholder in Oravax, along with Premas Biotech, MyMD Pharmaceuticals, and certain other shareholders with a mission to bring an oral COVID-19 vaccine to the market. Oravax combines cutting-edge vaccine technology acquired from Premas Biotech and the proprietary POD™ oral delivery technology of Oramed Pharmaceuticals.
For more information, please visit www.ora-vax.com
About Oramed Pharmaceuticals
Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 studies and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule.
For more information, please visit www.oramed.com.
Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss the potential of Oravax's vaccine to be more effective against current and future variants of COVID-19, the potential for future trials or potential emergency approval for Oravax's vaccine, the potential for Oravax's vaccine to be taken at home or the potential of ORMD-0801 to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, historic results of scientific research and clinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and finally that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed's reports filed from time to time with the Securities and Exchange Commission.
Company Contact
Joshua Hexter
+1-844-9-ORAMED
josh@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.
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